FDA to review MSD’s Keytruda as a first-line lung cancer treatment
pharmafile | September 7, 2016 | News story | Research and Development | FDA, MSD, Merck, first-line, keytruda, lung cancer, non-small cell lung cancer, opdivo
The US Food and Drug Administration has accepted the supplemental biologics license application from MSD, known as Merck in the US and Canada, for Keytruda (pembrolizumab) as a first-line treatment for patients with advanced non-small cell lung cancer.
MSD has already submitted an application to the EMA for the same indication, and was recently boosted by the failure of its chief rival, Bristol-Myers Squibb’s Opdivo (nivolumab), to meet the primary endpoint as a monotherapy in the same indication.
The application submitted to the FDA is for Keytruda to become a first-line treatment specifically for patients whose tumours express PD-L1. The submission is supported by data from the Phase III KEYNOTE-024 study, which showed significant improvements in progression-free survival and overall survival with Keytruda monotherapy compared to standard chemotherapy.
The FDA has also granted breakthrough therapy designation for Keytruda in this indication, after the trial was stopped early to give patients the option of receiving Keytruda.
Dr Roger Perlmutter, president at Merck Research Laboratories, says: “Chemotherapy has been the foundation of first-line treatment for non-small cell lung cancer for decades, so the significant improvement in survival in patients with high PD-L1 expression seen with Keytruda compared to chemotherapy is welcome news. We appreciate the opportunity to work with regulatory authorities to make Keytruda a first-line treatment option in non-small cell lung cancer.”
Sean Murray
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